Meet the team:The Staff Design Quality Engineer (Global Expansions) serves as the principal technical authority for design control, product risk management, and regulatory compliance across international markets. This role is vital for driving the regional adaptation, platform expansion, and localization of new and existing products. The ideal candidate ensures that local design requirements are fully integrated into our global product development lifecycle
Working cross-functionally with Systems Engineering, Design Engineering, Clinical, Regulatory Affairs, Quality, Manufacturing, Human Factors, and Post-Market Surveillance, this role integrates global medical device regulations - including FDA 21 CFR Part 820/QMSR, ISO 13485, EU MDR, ISO 14971 etc - into product development while ensuring patient safety and regulatory compliance.
Where you come in: - You will serve as the subject matter expert (SME) responsible for aligning Design History Files (DHFs) with the compliance requirements of target international markets
- You will act as the core team lead Quality Lead responsible for assessing the impact of change controls, CAPA's and Non Conformance's on the overall system
- You will serve as the lead Quality contact for requests from regulatory agencies as part of global expansions
- You will act as the Quality Lead responsible for supporting investigations from CAPA's and complaint investigations
- You will serve as the Quality Lead responsible for identifying, prioritizing, communicating, and resolving quality issues
What makes you successful: - You have proven experience in Design Quality Engineering and Assurance within the medical device industry.
- You must have a minimum of 8+ years of experience in medical device development.
- You bring at least 5+ years in leading and implementing global expansions in medical device development
- You demonstrate an ability to collaborate with cross functional teams.
- You possess exceptional interpersonal, written, and verbal communication skills.
- You are self-motivated with a collaborative, proactive, and accountable approach
What you'll get: - A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community.
- A full and comprehensive benefits program.
- Growth opportunities on a global scale.
- Access to career development through in-house learning programs and/or qualified tuition reimbursement.
- An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.
Travel Required: Experience and Education Requirements:- Typically requires a Bachelor's degree in a technical discipline, and a minimum of 8-12 years related experience or Master's degree and 5-7 years equivalent industry experience or a PhD and 2-4 years of experience.
Remote Workplace: Your location will be a home office; you are not required to live within commuting distance of your assigned Dexcom site (typically 75 miles/120km). If you reside within commuting distance of a Dexcom site (typically 75 miles/120km) a hybrid working environment may be available. Ask about our Flex workplace option.
Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
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Salary:
$111,100.00 - $185,100.00
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